Approval of Drug/Device Combination Products

Achieving regulatory compliance for drug/device products

Many of today’s most innovative medical devices are actually drug/device combination products that generally include a medical device part and a drug part. Combination products are often medical devices that have been coated or impregnated with a drug substance, such as a catheter with an antimicrobial coating, or a drug coated stent. Other examples of combination products include coated balloon catheters and bone cements containing antibiotic and condoms coated with spermicides.

Regulatory landscape for drug/device products

Despite the clinical advantages offered by combination products in treating certain medical conditions, the regulatory review and approval process for combination products is generally more complex than that applicable to non-combination products. In the European Union (EU), for example, the evaluation by a Notified Body of medical devices incorporating medicinal substances must include an opinion of a competent authority designated by an EU Member State, a process that can take more than 210 days (210 days + clocks stops) to complete. In the U.S., the Food and Drug Administration (FDA) handles the pre-market review of combination products through its Office of Combination Products (OCP), which then determines the appropriate process based on a review of the device’s primary mode of action (PMA). However, this determination alone can take up to two months before the actual pre-market review commences.

Manufacturers of combination products are encouraged to develop a detailed regulatory strategy as early as possible in the development process for new combination products. An effective regulatory strategy can provide a detailed plan and schedule for the regulatory approval process that is consistent with the manufacturer’s plans for market introduction. Combination product manufacturers should also seek advice from regulators, authorities and competent third-parties regarding the documentation required to support CE mark approval applications, including clinical evaluation reports, drug file (CTD-Format) and technical documentation. These steps serve to make the approval process as efficient as possible, and can help reduce the risk of unexpected challenges and setbacks that can prolong or jeopardise product approval.
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Why choose TÜV SÜD

Product Service experts understand drug/device combination products and can conduct a pre-assessment of the clinical evaluation report for the product prior to submission. In addition, TÜV SÜD Product Service has a global staff of medical device experts, with over 400 international specialists located in major markets around the world. These specialists are supported by TÜV SÜD Product Service’s own Clinical Centre of Excellence, and a scientific advisory board comprised of scientists and physicians from the leading universities and healthcare centres.

Our services at a glance

Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.

FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD Product Service medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.

Other testing and certification services - In addition to expertise in drug/device combination products, TÜV SÜD Product Service can pre-assess the compliance of devices with other relevant regulations and standards such as ATMP/Medical device combination sterilisation and risk analysis requirements.

Your benefits at a glance

Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world and is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.

Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.

Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.